FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
TROPHON
K Number: K103059
·
Decision Feb 24, 2011
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
6
Review Days
132
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Basic Information
- Device Name
- TROPHON
- K Number
- K103059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanosonics Limited
- Date Received
- October 15, 2010
- Decision Date
- February 24, 2011
- Product Code
- OUJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUJ), ordered by most recent decision date.
trophon2
FDA 510(k)
FDA Class 2
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trophon Wireless Ultrasound Probe Holder
FDA 510(k)
FDA Class 2
·Radiology
trophon2
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Nanosonics Limited
| K Number | Device Name | ||
|---|---|---|---|
| K253267 | CORIS System | Mar 5, 2026 | Substantially Equivalent |
| DEN240018 | CORIS System | Mar 19, 2025 | Unknown |
| K241536 | trophon Wireless Ultrasound Probe Holder | Sep 27, 2024 | Substantially Equivalent |
| K173865 | trophon2 | Apr 24, 2018 | Substantially Equivalent |
| K103126 | TROPHON CHEMICAL INDICATOR | Mar 3, 2011 | Substantially Equivalent |